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CompletedNCT03301298Updated Sep 26, 2019Results posted

Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

A Phase 1 interventional study of SXC-2023 and Placebo oral capsule in Healthy, sponsored by Promentis Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Promentis Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Promentis Pharmaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive).
  2. Medically healthy with no screening results.
  3. Non-vasectomized male subjects must agree to use or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo.
  4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
  5. Understands the study procedures in the form, and be willing and able to comply with the protocol

Exclusion criteria

Exclusion Criteria:

  1. Subject is mentally or legally incapacitated.
  2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
  3. History or presence of alcoholism or drug abuse within the past 2 years
  4. Female subject of .
  5. Blood donation or significant blood loss within 56 days prior to first dose.
  6. Plasma donation within 7 days prior to first dose.
  7. Participation in another clinical trial within 30 days prior to first dose.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    SXC-2023, 50 mg

    Single dose of 50 mg, given orally in capsule form.

    Drug: SXC-2023

  • Experimental
    SXC-2023, 100 mg

    Single dose of 100 mg, given orally in capsule form.

    Drug: SXC-2023

  • Experimental
    SXC-2023, 200 mg

    Single dose of 200mg, given orally in capsule form.

    Drug: SXC-2023

  • Experimental
    SXC-2023, 400 mg

    Single dose of 400mg, given orally in capsule form.

    Drug: SXC-2023

  • Experimental
    SXC-2023, 800 mg

    Single dose of 800mg, given orally in capsule form.

    Drug: SXC-2023

  • Experimental
    SXC-2023, 1600 mg

    Single dose of 1600 mg, given orally in capsule form.

    Drug: SXC-2023

  • Placebo comparator
    Placebo oral capsule

    Placebo comparator, given once orally in matching capsule form.

    Drug: Placebo oral capsule

Interventions

  • DrugSXC-2023

    Oral capsule

  • DrugPlacebo oral capsule

    Placebo given as oral capsule.

06

What researchers measure

Primary outcomes

  1. Number of Subjects Experiencing TEAEs.

    Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.

    Time frame: 8 days

Secondary outcomes

  1. Pharmacokinetic Assessments: Cmax

    Peak plasma concentration

    Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

  2. Pharmacokinetics Assessments: Tmax

    Time to peak plasma concentration

    Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

  3. Pharmacokinetic Assessments: AUC

    Area under the plasma concentration-time curve

    Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

  4. Pharmacokinetic: Food Effect, AUC

    To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

    Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

  5. Pharmacokinetic: Food Effect, CMax

    To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

    Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

07

Results

Posted Sep 26, 2019

Participant flow

Unfed Conditions
Participant flow — Unfed Conditions
MilestoneSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlacebo
Started66666612
Completed66666612
Not completed0000000
Fed Conditions
Participant flow — Fed Conditions
MilestoneSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlacebo
Started0000502
Completed0000502
Not completed0000000

Outcome measures

PrimaryNumber of Subjects Experiencing TEAEs.

Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.

Time frame:
8 days
Reported as:
Number · participants
Number of Subjects Experiencing TEAEs.
participantsSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlacebo Oral Capsule
Number of Subjects Experiencing TEAEs.3041214
SecondaryPharmacokinetic Assessments: Cmax

Peak plasma concentration

Time frame:
Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.
Reported as:
Geometric mean · ng/mL
Pharmacokinetic Assessments: Cmax
ng/mLSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mg
Pharmacokinetic Assessments: Cmax758.2 ± 157.32181 ± 58.35145 ± 38.19005 ± 60.425510 ± 49.533700 ± 35
SecondaryPharmacokinetics Assessments: Tmax

Time to peak plasma concentration

Time frame:
Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.
Reported as:
Mean · hours
Pharmacokinetics Assessments: Tmax
hoursSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mg
Pharmacokinetics Assessments: Tmax3.111 (3.01 to 4.02)3.016 (2.01 to 6)4 (2 to 6)4 (2 to 4.01)2.501 (1.5 to 6)3.5 (2 to 4)
SecondaryPharmacokinetic Assessments: AUC

Area under the plasma concentration-time curve

Time frame:
Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.
Reported as:
Geometric mean · ng*hr/mL
Pharmacokinetic Assessments: AUC
ng*hr/mLSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mg
Pharmacokinetic Assessments: AUC3213 ± 154.19732 ± 73.925180 ± 43.257170 ± 54139500 ± 28.6239700 ± 29.8
SecondaryPharmacokinetic: Food Effect, AUC

To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

Time frame:
Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.
Reported as:
Geometric mean · ng*hr/mL
Pharmacokinetic: Food Effect, AUC
ng*hr/mLSXC-2023, 800 mg Fed
Pharmacokinetic: Food Effect, AUC158700 ± 31.4
SecondaryPharmacokinetic: Food Effect, CMax

To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

Time frame:
Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.
Reported as:
Geometric mean · ng/mL
Pharmacokinetic: Food Effect, CMax
ng/mLSXC-2023, 800 mg Fed
Pharmacokinetic: Food Effect, CMax17160 ± 26.3

Adverse events

Collected over Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SXC-2023, 50 mg0/6 (0%)0/6 (0%)3/6 (50%)
SXC-2023, 100 mg0/6 (0%)0/6 (0%)0/6 (0%)
SXC-2023, 200 mg0/6 (0%)0/6 (0%)4/6 (66.7%)
SXC-2023, 400 mg0/6 (0%)0/6 (0%)1/6 (16.7%)
SXC-2023, 800 mg0/6 (0%)0/6 (0%)2/6 (33.3%)
SXC-2023, 1600 mg0/6 (0%)0/6 (0%)1/6 (16.7%)
Placebo0/12 (0%)0/12 (0%)4/12 (33.3%)
Most frequent other events
Showing 10 of 28
Most frequent other events
EventSXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlacebo
HeadacheNervous system disorders3/60/61/60/61/60/62/12
PhotophobiaEye disorders0/60/60/60/61/60/60/12
Abdominal PainGastrointestinal disorders0/60/61/60/60/60/60/12
ConstipationGastrointestinal disorders0/60/61/60/60/61/60/12
Dry mouthGastrointestinal disorders0/60/61/60/60/60/60/12
Mouth ulcerationGastrointestinal disorders0/60/61/60/60/60/60/12
NauseaGastrointestinal disorders1/60/61/60/60/60/61/12
VomitingGastrointestinal disorders1/60/61/60/60/60/60/12
Feeling hotGeneral disorders1/60/60/60/60/60/60/12
ThirstGeneral disorders0/60/61/60/60/60/60/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
<=18 years00000000
Between 18 and 65 years6666661248
>=65 years00000000
Age, Continuous
Age, Continuous(years)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
Mean40.5 ± 11.2638 ± 13.9343.3 ± 9.3542.8 ± 14.4138.7 ± 9.0940 ± 5.7343.3 ± 9.4341.3 ± 10.15
Sex: Female, Male
Sex: Female, Male(Participants)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
Female324323623
Male342343625
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
Hispanic or Latino4345561037
Not Hispanic or Latino232110211
Unknown or Not Reported00000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
American Indian or Alaska Native10000001
Asian00000000
Native Hawaiian or Other Pacific Islander00000000
Black or African American02000013
White5366661143
More than one race01000001
Unknown or Not Reported00000000
Region of Enrollment
Region of Enrollment(participants)SXC-2023, 50 mgSXC-2023, 100 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgPlaceboTotal
United States6666661248
08

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Feb 2018, 5 months.

Results were first posted in Sep 2019, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Oct 4, 2017
StartActual
Sep 11, 2017
Primary completionActual
Feb 13, 2018
CompletionActual
Feb 13, 2018
Results first posted
Sep 26, 2019
Last update
Sep 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03301298
Lead sponsor
Promentis Pharmaceuticals, Inc.
Collaborators
Celerion
Responsible party
Sponsor
First posted
Oct 4, 2017
Start date
Sep 11, 2017
Primary completion
Feb 13, 2018
Completion
Feb 13, 2018
Results posted
Sep 26, 2019
Last update
Sep 26, 2019

Study contacts

Tricia Cotter
study director · Promentis Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: SXC-2023

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Promentis Pharmaceuticals, Inc.

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